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Inhalation SLIT Cisplatin (Liposomal) for the Treatment of Osteosarcoma Metastatic to the Lung

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Insmed Incorporated
ClinicalTrials.gov Identifier:
NCT00102531
First received: January 29, 2005
Last updated: July 5, 2017
Last verified: July 2017
January 29, 2005
July 5, 2017
January 12, 2005
March 2008   (Final data collection date for primary outcome measure)
The Study Medication Was to be Considered Effective if the Population Response Rate Was Found to be Greater Than 20% and Individuals Who Demonstrated a CR or PR or Whose Tumours Demonstrated a Grade 3 or 4 Histologic Response at the Time of Surgery. [ Time Frame: 4 to 48 weeks ]
  • Safety
  • Response
  • Pharmacokinetics
Complete list of historical versions of study NCT00102531 on ClinicalTrials.gov Archive Site
Not Provided
Duration of response
Not Provided
Not Provided
 
Inhalation SLIT Cisplatin (Liposomal) for the Treatment of Osteosarcoma Metastatic to the Lung
Phase Ib/IIa Study of SLIT Cisplatin by Inhalation in the Treatment of Patients Wtih Relapsed/Progressive Osteosarcoma Metastatic to the Lung
Phase Ib/IIa open label safety and efficacy study designed to determine the maximum tolerated dose of inhaled cisplatin liposomal (SLIT cisplatin) administered every 14 days to patients with relapsed/progressive osteosarcoma metastatic to the lung.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Osteosarcoma Metastatic
Drug: Cisplatin liposomal
Other Name: SLIT Cisplatin
  • Experimental: Cisplatin liposomal 24 mg/m2
    Inhaled liposomal cisplatin was administered over 1 day in a 14-day treatment cycle by inhalation for a maximum of 6 cycles.
    Intervention: Drug: Cisplatin liposomal
  • Experimental: Cisplatin liposomal 36 mg/m2
    The study allowed for a dose escalation of liposomal cisplatin to 36 mg/m2 if no adverse events of Grade 3 or higher occurred after at least 3 cycles of drug administration at 24 mg/m2
    Intervention: Drug: Cisplatin liposomal
Chou AJ, Gupta R, Bell MD, Riewe KO, Meyers PA, Gorlick R. Inhaled lipid cisplatin (ILC) in the treatment of patients with relapsed/progressive osteosarcoma metastatic to the lung. Pediatr Blood Cancer. 2013 Apr;60(4):580-6. doi: 10.1002/pbc.24438. Epub 2012 Dec 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19
March 17, 2008
March 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically proven, Progressive or recurrent high grade osteosarcoma metastatic to the lung
  • Patients with histologically proven, fully malignant high-grade osteosarcoma of bone
  • Measureable pulmonary metastases
  • Less than grade 3 neuropathies, insignificant decreases in cardiac or auditory function
  • ECOG performance status of 0, 1 or 2
  • FEV1 of 50% or greater of predicted value
  • FEV1/FVC ratio of 65% or greater
  • Serum creatinine of ≤ 1.5 mg/dl
  • Total bilirubin ≤ 1.5mg/dl and SGOT or SGPT < 2.5 times upper normal limit
  • ANC of ≥ 1,000/mm3 and platelet count of ≥ 100,000/mm3

Exclusion Criteria:

  • Grade 3 or higher painful neuropathy persisting after a prior platinum containing regimen
  • Patients who are pregnant or are of childbearing potential and not using methods to avoid pregnancy
  • Concurrent systemic chemotherapy
  • Greater than Grade 2 pulmonary toxicity
  • Pulmonary atelectasis
  • Reactive airway disease which has resulted in hospitalization within the last year or which requires daily treatment with bronchodilator therapy
  • Concurrent serious infections
  • Unstable or serious concurrent medical condition
  • Recent major surgery or thoracic radiation therapy or chemotherapy
  • Significant pulmonary fibrosis secondary to prior radiation
  • Major ventilatory distribution abnormalities
  • Osteosarcoma secondary to radiation or premalignant conditions
  • History of prior malignancy
  • Low grade osteosarcoma, parosteal or periosteal sarcoma
Sexes Eligible for Study: All
13 Years to 50 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00102531
TR02-2421
Not Provided
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Undecided
Insmed Incorporated
Insmed Incorporated
Not Provided
Study Chair: Renu Gupta, MD Transave Inc.
Principal Investigator: Richard Gorlick, MD The Albert Einstein College of Medicine Montefiore Medical Center
Insmed Incorporated
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP